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Opus Spinal System

by Howmedica Osteonics Corp. 2 variants

510(k) K030369

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK030369 Date8 Aug 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
NKB
Device class
Class II
Regulation
21 CFR Part 888.3070
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Opus Spinal System is a spinal fixation appliance for non-cervical posterior spine stabilization. System components include conical/cylindrical bone screws, 6mm diameter rods, lateral connectors, and 2-3 hole plates. It is intended for posterior, noncervical pedicle and non-pedicle fixation for degenerative disc disease.

The device is supplied by Howmedica Osteonics Corp. and has FDA 510(k) clearance K030369. It is regulated under product code NKB for orthopedic use. The system is not specified as single-use or reusable, and no MRI safety information is provided.

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Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Opus Spinal System used for?

    The Opus Spinal System is a spinal fixation appliance intended for posterior, non-cervical pedicle and non-pedicle fixation to stabilize the spine, specifically for degenerative disc disease.

  • What components are included in the system?

    The system includes conical or cylindrical bone screws, 6mm diameter rods, lateral connectors, and 2-3 hole plates.

  • Is the device intended for single use?

    The device is not specified as single-use or reusable, so its intended use for reuse is not defined.

  • How is the device supplied?

    The Opus Spinal System is supplied by Howmedica Osteonics Corp.